NAFDAC Alerts Nigerians Over US Recall of Children’s Ibuprofen Over Contamination Fears

The National Agency for Food and Drug Administration (NAFDAC) has issued a public safety alert following the recall of approximately 90,000 bottles of ibuprofen oral suspension for children in the United States over contamination concerns.

The product in question, commonly used to relieve fever, pain, sore throat, headache and flu-related ailments in children, was recalled after the U.S. Food and Drug Administration confirmed reports of foreign materials found in some batches.

According to US regulators and the manufacturer, Strides Pharma (Strides Pharma), consumers reported the presence of a “gel-like mass” and black particles in the drug, prompting an immediate voluntary recall.

The product, Ibuprofen Oral Suspension for Children, USP (100 mg/5 ml), is manufactured by Strides Pharma in India for Taro Pharmaceuticals (Taro Pharmaceuticals) and distributed in the United States in 120 ml bottles.

NAFDAC said the development raises serious concerns about product quality and patient safety, warning that the presence of foreign materials in medicines could compromise their effectiveness and pose health risks, especially to children.

The affected lots are identified as lot numbers 7261973A and 7261974A, with an expiration date of January 31, 2027.

Although the recall was carried out in the United States, Nigeria’s drug regulator said it is taking proactive measures to ensure the products do not enter the Nigerian market.

NAFDAC revealed that all zonal directors and state coordinators have been directed to intensify surveillance on pharmaceutical outlets, import channels and distribution networks nationwide.

It also urged importers, distributors, healthcare professionals and pharmaceutical operators to remain vigilant and avoid the importation, sale or circulation of the affected batches.

Parents and carers have also been advised to stop using any products matching the description and batch numbers, while those who notice any unusual reactions in children are encouraged to seek immediate medical attention.

The agency added that healthcare facilities should urgently review their inventories and quarantine all suspected products pending further instructions.

NAFDAC reiterated its commitment to safeguarding public health, saying it will continue to monitor global drug safety alerts and take necessary actions to protect Nigerians from substandard or unsafe drugs.

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